A Phase II randomised, double-blind, parallel-group, multicentre, international trial to investigate the safety and efficacy of vicadrostat and empagliflozin administered with simultaneous vs staggered initiation in participants with chronic kidney disease at risk of kidney disease progression

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518457-42-00

Acronym

1378-0023

Enrollment

100

Registered

2025-08-04

Start date

2025-08-28

Completion date

Unknown

Last updated

2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney disease

Brief summary

absolute change in eGFR (mL/min/1.73m2) from baseline to Week 14

Detailed description

Absolute change in eGFR (mL/min/1.73m2) from baseline to Week 12, Absolute change in SBP (mmHg) from baseline to Week 12, Relative change (ratio) in UACR from baseline to Week 6, Absolute change in serum potassium (mmol/L) from baseline to Week 12

Interventions

DRUGBI 690517

DRUGPlacebo matching vicadrostat

DRUGJardiance 10 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
absolute change in eGFR (mL/min/1.73m2) from baseline to Week 14	—

Secondary

Measure	Time frame
Absolute change in eGFR (mL/min/1.73m2) from baseline to Week 12, Absolute change in SBP (mmHg) from baseline to Week 12, Relative change (ratio) in UACR from baseline to Week 6, Absolute change in serum potassium (mmol/L) from baseline to Week 12	—

Countries

Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026